UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051224 |
|---|---|
| Receipt number | R000058403 |
| Scientific Title | Treatment Preferences for Patients with Esophageal Cancer in Japan |
| Date of disclosure of the study information | 2023/06/12 |
| Last modified on | 2024/07/02 14:23:31 |
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Basic information
Public title
Treatment Preferences for Patients with Esophageal Cancer in Japan
Acronym
PPEC Study
Scientific Title
Treatment Preferences for Patients with Esophageal Cancer in Japan
Scientific Title:Acronym
PPEC Study
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clarify what esophageal cancer patient value as treatment strategies
Basic objectives2
Others
Basic objectives -Others
To clarify the profile of drugs emphasized by patients with esophageal cancer as treatment methods and the trade-offs related to efficacy and safety in esophageal cancer treatment
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
DCE-based relative importance of attributes in patients with esophageal cancer
Key secondary outcomes
Trade-offs between DCE-based attributes and subgroup analyses based on patient and clinical characteristics in patients with esophageal cancer
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Signed informed consent
2. Age18 years or more
3.Self reported esophageal cancer
Key exclusion criteria
None
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Matsumoto |
Organization
Ono Pharmaceutical Co., Ltd.
Division name
Oncology Medical , Medical Affairs
Zip code
103-0023
Address
9-11, Nihonbashi-Honcho 4-Chome Chuo-ku, Tokyo
TEL
03-5640-3711
hi.matsumoto@ono-pharma.com
Public contact
Name of contact person
| 1st name | Tshioaki |
| Middle name | |
| Last name | Murofushi |
Organization
INTAGE Healthcare, Inc
Division name
Market Access, Marketing Insight
Zip code
101-0062
Address
Ochanomizu Sola City 13F Kanda Surugadai 4-6 Chiyoda-ku, Tokyo
TEL
03-5294-8393
Homepage URL
toshiaki.murofushi@intage.com
Sponsor or person
Institute
Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb K.K.
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ono Pharmaceutical Co.,ltd.
Address
8-2,Kyuutaromachi1-chome,Chuo-ku, osaka-shi,Osaka
Tel
06-6263-5670
n.nishiwaki@ono-pharma.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 06 | Month | 01 | Day |
Last modified on
| 2024 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058403
